(321 days)
Not Found
No
The document describes image processing techniques based on dual-energy CT data and pre-defined algorithms for specific clinical tasks. There is no mention of AI, ML, or learning from data.
No.
The device is a post-processing application for CT images, designed to improve visualization and support diagnosis, not to provide therapy.
Yes
This device is designed to provide information on the chemical composition of scanned body materials, visualize specific conditions like gout and brain hemorrhage, and differentiate between types of kidney stones, which are all diagnostic functions. The "Intended Use / Indications for Use" section explicitly states these diagnostic applications.
Yes
The device is explicitly described as a "Software Package" and a "post processing application package" that operates on a client-server platform. It processes existing CT images and does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a post-processing application for CT images to improve visualization of different materials in the human body. It aids in the differentiation of materials based on their attenuation coefficients at different energy levels. While it supports the visualization of kidney stone composition, it explicitly states that "For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information." This indicates it's a tool to assist in diagnosis, not a diagnostic test performed in vitro on biological specimens.
- Device Description: The device is described as a "post processing application package" that operates on CT images. It performs image processing and visualization.
- Nature of the Test: The device analyzes in vivo imaging data (CT scans of the patient's body), not in vitro samples (like blood, urine, or tissue).
IVD devices are specifically designed to perform tests on specimens taken from the human body in vitro to provide information for diagnostic purposes. This device operates on images acquired in vivo.
N/A
Intended Use / Indications for Use
syngo. CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Single Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Single Source Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The functionality of the syngo.CT Single Source Dual Energy applications is as follows:
- · Monoenergetic
- Gout Evaluation
- · Brain Hemorrhage
- · Liver VNC
- · Monoenergetic Plus
- Bone Marrow
- · Kidney Stones*)
*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
syngo.CT Single Source Dual Energy Software Package is a post processing application package consisting of several post processing application classes that can be used to improve visualization of various materials in the human body.
syngo.CT Single Source Dual Energy is a post processing software package designed to operate on the most recent version syngo.via client server platform, which supports preprocessing and loading of datasets by syngo.via depending on configurable rules.
After loading the two reconstructed image datasets acquired with two different X-ray spectra into syngo.CT Single Source Dual Energy, a registration is performed in case the image data sets are not acquired simultaneously, to compensate for potential motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale. Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view.
After arriving at an initial diagnosis on the basis of the CT-images, the user can choose one of the following application classes:
- Gout Evaluation
- . Monoenergetic
- Brain Haemorrhage
- LiverVNC
- Kidney Stones
- . Monoenergetic Plus
- Bone Marrow
These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) are optimized correspondingly.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Anatomical region of interest, human body, organ of interest, brain, liver, bone marrow, kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Well-trained radiologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Performance studies and phantom studies were conducted to test the functionality of the syngo.CT Dual Energy post processing applications. A phantom study was performed to test the ability of application kidney stones.
The result of this study demonstrated that application Kidney Stones is able to differentiate between uric acid and non-uric acid stones. Furthermore clinical data have been used to demonstrate the functionality of the other application classes.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance studies and phantom studies were conducted to test the functionality of the syngo.CT Dual Energy post processing applications. A phantom study was performed to test the ability of application kidney stones.
The result of this study demonstrated that application Kidney Stones is able to differentiate between uric acid and non-uric acid stones. Furthermore clinical data have been used to demonstrate the functionality of the other application classes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2014
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Technical Specialist 51 Valley Stream Parkway MALVERN PA 19355
Re: K133677
Trade/Device Name: syngo.CT Single Source Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 10, 2014 Received: September 17, 2014
Dear Ms. Mangum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Smh
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K133677
Device Name syngo.CT Single Source Dual Energy
Indications for Use (Describe)
syngo. CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Single Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Single Source Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The functionality of the syngo.CT Single Source Dual Energy applications is as follows:
- · Monoenergetic
- Gout Evaluation
- · Brain Hemorrhage
- · Liver VNC
- · Monoenergetic Plus
- Bone Marrow
- · Kidney Stones*)
*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.
Type of Use (Select one or both, as applicable)
|× Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
FOR
synqo.CT Single Source Dual Energy Software Package
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: September 8, 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. General Information
Importer/Distributor:
Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Establishment Registration Number: 2240869
Manufacturing Site:
Siemens AG Medical Solutions Henkestraße 127 D-91052 Erlangen, Germany
Establishment Registration Number: 3002808157
2. Contact Person:
Mrs. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly.mangum@siemens.com
3. Device Name and Classification
| Product Name: | syngo.CT Single Source Dual Energy |
|---|---|
| Propriety Trade Name: | syngo.CT Single Source Dual Energy |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
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| CFR Section: | 21 CFR §892.1750 |
|---|---|
| Device Class: | Class II |
| Product Code: | 90JAK |
Legally Marketed Predicate Devices SOMATOM DRI X-Ray Scanner CT System Trade Name: 510(k)#: K837107 Clearance Date: March 09, 1983 System, X-Ray, Tomography, Computed Classification Name: Classification Panel: Radiology Classification Regulation:21 CFR § 892.1750 Device Class: ll Product Code: JAK
| Trade Name: | syngo® Dual Energy with extended functionality |
|---|---|
| 510(k)#: | K083524 |
| Clearance Date: | April 01, 2009 |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR § 892.1750 |
| Device Class: | II |
| Product Code: | 90 JAK |
| Trade Name: | syngo® Single Source Dual Energy |
|---|---|
| 510(k)#: | K122909 |
| Clearance Date: | December 27, 2012 |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR § 892.1750 |
| Device Class: | II |
| Product Code: | 90 JAK |
4. Substantial Equivalence:
The subject device syngo.CT Single Source Dual Energy software package is substantially equivalent to following medical devices in commercial distribution:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| syngo® Dual Energy Software Package | K083524 | April 1, 2009 |
| syngo® Single Source Dual Energy Software Package | K122909 | December 27, 2012 |
| SOMATOM DRI X-Ray Scanner CT System | K837107 | March 09, 1983 |
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5. Device Description:
Dual energy offers functions for qualitative and quantitative evaluations. Dual energy CT can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT.
Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms. syngo.CT Single Source Dual Energy Software Package is a post processing application package consisting of several post processing application classes that can be used to improve visualization of various materials in the human body.
syngo.CT Single Source Dual Energy is a post processing software package designed to operate on the most recent version syngo.via client server platform, which supports preprocessing and loading of datasets by syngo.via depending on configurable rules.
After loading the two reconstructed image datasets acquired with two different X-ray spectra into syngo.CT Single Source Dual Energy, a registration is performed in case the image data sets are not acquired simultaneously, to compensate for potential motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale. Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view.
After arriving at an initial diagnosis on the basis of the CT-images, the user can choose one of the following application classes:
- Gout Evaluation
- . Monoenergetic
- Brain Haemorrhage
- LiverVNC
- Kidney Stones
- . Monoenergetic Plus
- Bone Marrow
These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) are optimized correspondingly.
6. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
syngo.CT Single Source Dual Energy Software Package is a post processing application operating on the multi-user syngo.via client server platform. The subject syngo.CT Single Source Dual Energy provides similar evaluation,
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reporting and visualization tools, and functionality as the predicate device syngo® Single Source Dual Energy. This includes image processing and visualization tools such as basic visualization of various energy dependent materials in the human body and VRT visualization. In addition to the previously cleared Monoenergetic and Gout Evaluation single source dual energy applications, syngo.CT Single Source Dual Energy also supports the following single source dual energy post processing application classes:
- Brain Haemorrhage
- · Liver VNC
- · Monoenergetic Plus
- Bone Marrow
- Kidney Stones
syngo.CT Single Source Dual Energy does not have significant changes in technological characteristics when compared to the predicate devices. The Indication for Use, operating principle, and the scientific technology are similar; therefore, Siemens believes that syngo.CT Single Source Dual Energy Package is substantially equivalent to the predicate devices.
7. Nonclinical Testing:
syngo.CT Single Source Dual Energy Software Package is designed to fulfill the requirements of following standards:
- IEC 60601-1-6 : 2007; Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral Standard: Usability
- IEC 60601-1-4:2000; Consol. Ed. 1.1, Medical electrical equipment Part . 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1
- IEC 62304 Ed. 1.0, "Medical Device Software Software Lifecycle ● Processes"
- ISO 14971:2007; Medical devices Application of risk management to ● medical devices
- Digital Imaging and Communications in Medicine (DICOM) Set Standard: 2008 DICOM conformity is fully covered by syngo.via implementations.
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) and phantom testing were conducted for syngo.CT Single Source Dual Energy during product development. The modifications described in the Premarket Notification were supported with verification/validation as well as phantom testing.
Performance studies and phantom studies were conducted to test the functionality of the syngo.CT Dual Energy post processing applications. A phantom study was performed to test the ability of application kidney stones.
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The result of this study demonstrated that application Kidney Stones is able to differentiate between uric acid and non-uric acid stones. Furthermore clinical data have been used to demonstrate the functionality of the other application classes.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
Summary of Additional Testing
In addition to successful completion of verification and validation testing, additional bench testing was performed to substantiate performance claims and demonstrate substantial equivalence to the predicate devices. Sample clinical images were also provided within the submission.
8. Indications for Use:
syngo.CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Single Source scanners. The various materials of an anatomical reqion of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Single Source Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The functionality of the syngo.CT Single Source Dual Energy applications is as follows:
- Monoenergetic
- Gout Evaluation ●
- Brain Hemorrhage ●
- Liver VNC ●
- Monoenergetic Plus ●
- Bone Marrow
- Kidney Stones®
*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone
9
additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.
9. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development. verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
10. Conclusion as to Substantial Equivalence
In summary, Siemens is of the opinion that the syngo.CT Single Source Dual Energy Software Package does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.